MX2022012248A - Formulacion pediatrica de inhibidores de tirosina quinasa. - Google Patents

Formulacion pediatrica de inhibidores de tirosina quinasa.

Info

Publication number
MX2022012248A
MX2022012248A MX2022012248A MX2022012248A MX2022012248A MX 2022012248 A MX2022012248 A MX 2022012248A MX 2022012248 A MX2022012248 A MX 2022012248A MX 2022012248 A MX2022012248 A MX 2022012248A MX 2022012248 A MX2022012248 A MX 2022012248A
Authority
MX
Mexico
Prior art keywords
tyrosine kinase
kinase inhibitor
coated
kinase inhibitors
dosing
Prior art date
Application number
MX2022012248A
Other languages
English (en)
Inventor
Lois B Rosenberger
Gregory J Kelso
Steve Rosenberger
Original Assignee
Igia Pharmaceuticals Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Igia Pharmaceuticals Inc filed Critical Igia Pharmaceuticals Inc
Publication of MX2022012248A publication Critical patent/MX2022012248A/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
    • A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further heterocyclic rings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5036—Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042—Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
    • A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089—Processes

Landscapes

  • Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Una forma de dosificación pediátrica para dosificar dosis ultra bajas de un ingrediente farmacéuticamente activo que tiene una pluralidad de bolitas, en donde cada bolita consiste esencialmente de un recubrimiento de inhibidor de tirosina quinasa sobre una gragea. Las grageas recubiertas de inhibidor de tirosina quinasa están recubiertas sobre ellas con un recubrimiento que consiste esencialmente de hidroxipropil metilcelulosa. Las perlas recubiertas activas permiten la dosificación para un sujeto humano con base en mg/kg. La suma de tales bolitas forma una sola unidad de dosificación de una dosis ultra baja de inhibidor de tirosina quinasa.
MX2022012248A 2020-03-30 2021-03-30 Formulacion pediatrica de inhibidores de tirosina quinasa. MX2022012248A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202063001824P 2020-03-30 2020-03-30
PCT/US2021/024815 WO2021202478A1 (en) 2020-03-30 2021-03-30 Pediatric formulation of tyrosine kinase inhibitors

Publications (1)

Publication Number Publication Date
MX2022012248A true MX2022012248A (es) 2022-10-27

Family

ID=77922389

Family Applications (1)

Application Number Title Priority Date Filing Date
MX2022012248A MX2022012248A (es) 2020-03-30 2021-03-30 Formulacion pediatrica de inhibidores de tirosina quinasa.

Country Status (7)

Country Link
US (2) US20210308057A1 (es)
EP (1) EP4125913A4 (es)
JP (1) JP2023520021A (es)
CN (1) CN115397427A (es)
CA (1) CA3172749A1 (es)
MX (1) MX2022012248A (es)
WO (1) WO2021202478A1 (es)

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010024660A1 (en) * 1999-09-29 2001-09-27 Ismat Ullah Enteric coated pharmaceutical composition and method of manufacturing
CA2762179A1 (en) * 2009-05-18 2010-11-25 Sigmoid Pharma Limited Composition comprising oil drops
PE20141649A1 (es) * 2011-10-06 2014-11-14 Novartis Ag Composiciones farmaceuticas que comprenden 40-o-(2-hidroxi)etil-rapamicina
WO2014004707A1 (en) * 2012-06-29 2014-01-03 Principia Biopharma Inc. Formulations comprising ibrutinib
MX2016001096A (es) * 2013-07-25 2016-04-25 Basf Se Sales de dasatinib en forma amorfa.
US20170202789A1 (en) * 2014-07-16 2017-07-20 New World Pharmaceuticals, Llc Methods and related compositions for improved drug bioavailability and disease treatment
CN106459049B (zh) * 2015-06-03 2020-11-27 普林斯匹亚生物制药公司 酪氨酸激酶抑制剂
TW201718572A (zh) * 2015-06-24 2017-06-01 普林斯匹亞生物製藥公司 酪胺酸激酶抑制劑
EA036701B1 (ru) * 2015-12-16 2020-12-09 Синтон Б.В. Таблетированная фармацевтическая композиция, содержащая безводный дазатиниб
US10145855B2 (en) * 2016-05-03 2018-12-04 Synapse Biosciences, LLC Methods and dose packs for monitoring medication adherence

Also Published As

Publication number Publication date
US20240325310A1 (en) 2024-10-03
WO2021202478A1 (en) 2021-10-07
EP4125913A4 (en) 2023-08-23
US20210308057A1 (en) 2021-10-07
CA3172749A1 (en) 2021-10-07
CN115397427A (zh) 2022-11-25
EP4125913A1 (en) 2023-02-08
JP2023520021A (ja) 2023-05-15

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